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T/R ratio and the content of the active compound in each product [Power / Sample Size]

posted by CECIF - Colombia, 2017-10-11 18:18  - Posting: # 17887
Views: 1,984

I have been following the tutorial in biostatistics by SA Julious (2004, DOI:10.1002/sim.1783). There, he mentions that it is possible to expect a priory a T/R ratio different to the unity (in a extent 0.8 to 1.20). However it is not clear to me, what criteria or in which cases can I assume an apriori ratio as big as 0.8 or 1.20, if knowingly I am trying to demonstrate bioequivalence and then I should be expecting a T/R ratio of 1.00.

In a particular case I happen to have a test product with content of the active compound that is above 110% of the content of the reference product. Could this product be evaluated for bioequivalence, by designing a study with an apriori T/R ratio of 1.10?

Edit: Category changed; I think this one fits better (was “Design Issues”). [Helmut]

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